Primary Outcomes

Occurrence of CMV secondary infections determined in all seropositive subjects on samples collected during the 4-month Site Visits until study conclusion.

time frame:
Every 4 months from Month 0 to Month 36

Secondary Outcomes

Measure

Occurrence of CMV primary infections determined in all seronegative subjects in terms of antibody concentrations.

time frame:
Every 4 months from Month 0 to Month 36

Eligibility Criteria

Female participants from 10 years up to 17 years old.

Inclusion Criteria:
- A female adolescent between, and including 10 and 17 years at the time of enrolment
regardless of pregnancy status and contraception method used or not used.
- Subjects who the investigator believes that the subject and/or the subject's
parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the
requirements of the protocol.
- Written informed assent and/or consent obtained from the subject and/or the
parent(s)/LAR(s) of the subject.
- Subject is likely to remain in the area and/or return for required study Site Visits
and complete Sample Collection Visits.
Exclusion Criteria:
- Child in care.
- Use or planned use of any investigational or non-registered antiviral drug or vaccine
during the study period.
- Known medical history of any recurrent clinical herpes episodes requiring episodic or
chronic suppressive treatment with oral or parenteral antiviral treatment such as
acyclovir, famciclovir, valacyclovir or any other anti-herpes virus anti-viral during
the year preceding enrolment. Topical anti-viral are allowed.
- Subjects with history of previous vaccination against CMV.
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6
months prior to Visit 1 or planned administration during the study. Inhaled and
topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within 3 months prior to
Visit 1 or planned administration during the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including
HIV-infection, based on medical history and physical examination (no laboratory
testing required).
- Any major congenital defects, serious chronic illness or organ transplantation.

Additional Information

Official title

A Study in Adolescent Females to Explore Cytomegalovirus Infection

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.